Fda s Drug Approval Process History, Pre Market, And...

Hunter Larson Barbara Roark PLS 130 1 July 2015 The FDA’s Drug Approval Process: History, Pre-Market, and Post-Market I. Introduction The Food and Drug Administration is a regulation agency within the Department of Health and Human Services. It’s role in our nation is to be responsible for â€Å"protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation† (What We Do.). One of the most important responsibilities and the topic I will be discussing throughout this paper is drug regulation. The Food and Drug Administration approves drugs that are intended for use in diagnosis, cure, relief, treatment, or prevention of disease, and is intended to affect the function of the body. In order to do so, The Food and Drug Administration reviews drug manufacturer’s via application to put drugs on the market; therefore, a drug may not be sold or marketed unless it has and remains approved by the FDA. Even though a drug has been appr oved does not mean it will remain on the market, drugs have the likelihood to be recalled. For example, when you see those late night personal injury lawyer commercials saying, â€Å"If you have been prescribed and taken said drug, and experienced any of these side effects such as blood clots, seizures, etc., you may be entitled to compensation.† those drugs have usually been recalled due to adverse effectsShow MoreRelatedFda s Drug Approval Process : History, Pre Market, And Post Market1881 Words   |  8 PagesHunter Larson Prof. Barbara Roark PLS 130 1 July 2015 The FDA’s Drug Approval Process: History, Pre-Market, and Post-Market I. Introduction The Food and Drug Administration is a regulation agency within the Department of Health and Human Services. It’s role in our nation is to be responsible for â€Å"protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emitRead MoreClinical Trials And Its Effects On The Public Health Care Arena2654 Words   |  11 Pagesscience and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine related problem.† Regulated in the US by the Food and Drug Administration (FDA) with the expectation of volunteer reporting by health care professionals (HCP) and mandatory reporting by drug developers/manufacturers, this field of study is essential in the improvement of patient outcomes and safety. 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Product RD and Clinical Trials 4. Manufacturing and Process RD 5. Technological Factors Structure-Based Drug (Rational Drug) Design Structure-Based Drug (Rational Drug) Design 6. Merck 7. Managerial Decision Making 8. Decision Making on IT projects 9. Joint Ventures 10. Information Technology and Organization 11. Appendix I - Summary Answers to Questions